(87 days)
The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. The Spinal USA Anterior Lumbar Plate System is intended to be used with autograft as an adjunct to fusion.
The Spinal USA Anterior Lumbar Plate System consists of a range of plate and screw sizes. The plates come in sizes of: 21 mm, 23 mm, 27 mm. The screws come in 5.0mm and 5.5mm diameters and the screw lengths are 25mm, 30mm. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".
The provided text is a 510(k) summary for the Spinal USA Anterior Lumbar Plate System. This type of document is for a medical device that requires premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
The 510(k) summary does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of AI/machine learning. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on performance data relevant to its mechanical and material properties, and its intended use as a spinal fixation device.
Therefore, I cannot provide the requested information, which pertains to AI device evaluation, from this document. The document describes a traditional medical device (spinal plate system) and its regulatory clearance process, not an AI/machine learning component.
To be clear, the document does NOT contain:
- A table of acceptance criteria and reported device performance related to AI.
- Sample sizes or data provenance for a test set (in an AI context).
- Number or qualifications of experts for establishing ground truth (in an AI context).
- Adjudication method for a test set (in an AI context).
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study for AI.
- Information about a standalone algorithm performance study.
- Type of ground truth used (in an AI context).
- Sample size for a training set (in an AI context).
- How ground truth for a training set was established (in an AI context).
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510 (k) Summary of Safety and Effectiveness
Date Summary Prepared:
Submitter Information:
Contact Name: Phone: Fax: E-mail:
Spinal USA 2050 Executive Drive Pearl, MS 39208
jeff(@spinalusa.com
Jeffrey Johnson
601-420-4244 601-420-5501
888.3060
Class II
KWQ
April 10, 2009
KC91044
JUL - 9 2009
Spinal USA Anterior Lumbar Plate System
Spinal Fixation System
Common Name:
Device Trade Name:
Regulatory Number:
Classification:
Product Code:
Spinal USA Anterior Lumbar Plate System (K070922)
INTENDED USE:
Predicate Devices:
The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterclateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. The Spinal USA Anterior Lumbar Plate System is intended to be used with autograft as an adjunct to fusion.
DEVICE DESCRIPTION:
The Spinal USA Anterior Lumbar Plate System consists of a range of plate and screw sizes. The plates come in sizes of: 21 mm, 23 mm, 27 mm. The screws come in 5.0mm and 5.5mm diameters and the screw lengths are 25mm, 30mm. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".
EQUIVALENT DEVICE:
Documentation was provided which demonstrated the Spinal USA Anterior Lumbar Plate System to be substantially equivalent to its predicate devices with respect to performance data, intended use and indications, and basic principles of operation. As demonstrated by performance data, these technological differences do not present any new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle-like symbol with stylized wings and tail feathers. Encircling the symbol are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spinal USA Holdings Inc. % Mr. Jeffrey Johnson Regulatory Affairs Manager 2050 Executive Drive Pearl, Mississippi 39208
JUL - - 9 2009
Re: K091044
Trade/Device Name: Spinal USA Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 8, 2009 Received: June 11, 2009
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Jeffrey Johnson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Obalare Inuchur
Mark N. Melkei Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number : K091044
Device Name: Spinal USA Anterior Lumbar Plate System
Indications for Use:
The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (LI-S1) fixation for the following indications: degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. The Spinal USA Anterior Lumbar Plate System is intended to be used with autograft and/or allograft as an adjunct to fusion.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(EXT Forman)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091044
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.